Study of Efficacy and Safety of Brolucizumab Versus Panretinal Photocoagulation Laser in Patients With Proliferative Diabetic Retinopathy (CONDOR)

A 96-week, Two-arm, Randomized, Single-masked, Multi-center, Phase III Study Assessing the Efficacy and Safety of Brolucizumab 6 mg Compared to Panretinal Photocoagulation Laser in Patients With Proliferative Diabetic Retinopathy

The purpose of this study was to evaluate the efficacy and safety of brolucizumab compared to panretinal photocoagulation laser (PRP) in patients with proliferative diabetic retinopathy (PDR). This evaluation will provide information that brolucizumab is non-inferior to PRP with respect to the change in best corrected visual acuity at Week 54.

Study Overview

• Status: Completed
• Conditions: Proliferative Diabetic Retinopathy
• Intervention / Treatment: Biological: Brolucizumab 6 mg; Procedure: Panretinal photocoagulation laser

Detailed Description

Phase III, 96-week, two-arm, randomized (1:1 ratio), single-masked, multi-center, active-controlled study to evaluate the efficacy and safety of brolucizumab compared to Panretinal photocoagulation (PRP) in subjects with Proliferative diabetic retinopathy (PDR).

Subjects who consented underwent screening assessments to evaluate their eligibility based on the inclusion and exclusion criteria. Subjects who met all the inclusion and none of the exclusion criteria were randomized in a 1:1 ratio to one of the following treatments:

Brolucizumab 6 mg: 3 x q6w loading then q12w maintenance through Week 90, with the option from Week 48 onwards to extend the treatment interval by 6 weeks at a time up to 24 weeks, and revert to q12w if disease worsens. More frequent injection with q6w interval in the maintenance phase could be administered at the discretion of the Investigator if the disease worsens.

PRP: initial treatment in 1-4 sessions up to Week 12, followed with additional PRP treatment (may split into 2-4 sessions) as needed up to Week 90.

Visits occurred every 6 weeks throughout the study, regardless of treatment or not.

• Study Type: Interventional
• Enrollment (Actual): 689
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • CABA, Argentina, C1061AAE
    • Novartis Investigative Site
  • Buenos Aires
    • Caba, Buenos Aires, Argentina, 1116
      • Novartis Investigative Site
    • Ciudad Autonoma de Bs As, Buenos Aires, Argentina, C1015ABO
      • Novartis Investigative Site
  • De Santa Fe
    • Rosario, De Santa Fe, Argentina, B7602
      • Novartis Investigative Site
• Australia
  • New South Wales
    • Albury, New South Wales, Australia, 2640
      • Novartis Investigative Site
    • Liverpool, New South Wales, Australia, 2170
      • Novartis Investigative Site
    • Parramatta, New South Wales, Australia, 2150
      • Novartis Investigative Site
    • Strathfield, New South Wales, Australia, 2135
      • Novartis Investigative Site
• Brazil
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
      • Novartis Investigative Site
  • Santa Catarina
    • Blumenau, Santa Catarina, Brazil, 89052-504
      • Novartis Investigative Site
  • São Paulo
    • Sorocaba, São Paulo, Brazil, 18031-060
      • Novartis Investigative Site
    • São Paulo, São Paulo, Brazil, 01427-002
      • Novartis Investigative Site
• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K2B 7E9
      • Novartis Investigative Site
    • Toronto, Ontario, Canada, M5T 2S8
      • Novartis Investigative Site
  • Quebec
    • Boisbriand, Quebec, Canada, J7H 1S6
      • Novartis Investigative Site
    • Québec, Quebec, Canada, G1S 4L8
      • Novartis Investigative Site
• Chile
  • RM
    • Santiago, RM, Chile, 7560994
      • Novartis Investigative Site
• China
  • Beijing, China, 100730
    • Novartis Investigative Site
  • Beijing, China, 100050
    • Novartis Investigative Site
  • Beijing, China, 100191
    • Novartis Investigative Site
  • Shanghai, China, 200080
    • Novartis Investigative Site
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100044
      • Novartis Investigative Site
  • Guangdong
    • Shantou, Guangdong, China, 515041
      • Novartis Investigative Site
  • Hubei
    • Wuhan, Hubei, China, 430060
      • Novartis Investigative Site
    • Wuhan, Hubei, China, 430070
      • Novartis Investigative Site
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Novartis Investigative Site
    • Nantong, Jiangsu, China, 226000
      • Novartis Investigative Site
  • Jilin
    • Changchun, Jilin, China, 130041
      • Novartis Investigative Site
  • Liaoning
    • Shenyang, Liaoning, China, 110000
      • Novartis Investigative Site
  • Shaanxi
    • Xi'an, Shaanxi, China, 710004
      • Novartis Investigative Site
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Novartis Investigative Site
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300020
      • Novartis Investigative Site
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325027
      • Novartis Investigative Site
• India
  • Chandigarh, India, 160012
    • Novartis Investigative Site
  • New Delhi, India, 110 029
    • Novartis Investigative Site
  • Gujarat
    • Ahmedabad, Gujarat, India, 380 016
      • Novartis Investigative Site
  • Tamil Nadu
    • Coimbatore, Tamil Nadu, India, 641014
      • Novartis Investigative Site
    • Tirunelveli, Tamil Nadu, India, 627003
      • Novartis Investigative Site
• Japan
  • Akita, Japan, 010-8543
    • Novartis Investigative Site
  • Kobe, Japan, 650-0017
    • Novartis Investigative Site
  • Osaka, Japan, 545-8586
    • Novartis Investigative Site
  • Aichi-ken
    • Nagakute, Aichi-ken, Japan, 480-1195
      • Novartis Investigative Site
    • Nagoya, Aichi-ken, Japan, 466 8560
      • Novartis Investigative Site
  • Chiba
    • Sakura, Chiba, Japan, 285-8741
      • Novartis Investigative Site
  • Fukui
    • Yoshida-gun, Fukui, Japan, 910-1193
      • Novartis Investigative Site
  • Fukuoka
    • Kurume, Fukuoka, Japan, 830-0011
      • Novartis Investigative Site
  • Fukushima
    • Kōriyama, Fukushima, Japan, 963-8052
      • Novartis Investigative Site
  • Hokkaido
    • Asahikawa, Hokkaido, Japan, 078 8510
      • Novartis Investigative Site
  • Kagawa-ken
    • Kita-gun, Kagawa-ken, Japan, 761-0793
      • Novartis Investigative Site
  • Mie-ken
    • Tsu, Mie-ken, Japan, 514-8507
      • Novartis Investigative Site
  • Nagano
    • Matsumoto, Nagano, Japan, 390-8621
      • Novartis Investigative Site
  • Tochigi
    • Shimotsuke, Tochigi, Japan, 329-0498
      • Novartis Investigative Site
  • Tokyo
    • Chiyoda-ku, Tokyo, Japan, 101-8309
      • Novartis Investigative Site
    • Hachiōji, Tokyo, Japan, 193-0944
      • Novartis Investigative Site
    • Meguro-ku, Tokyo, Japan, 152-8902
      • Novartis Investigative Site
• Mexico
  • Mexico City, Mexico, 06760
    • Novartis Investigative Site
  • Tijuana, Mexico, 22010
    • Novartis Investigative Site
  • Mexico City
    • Ciudad de, Mexico City, Mexico, 06800
      • Novartis Investigative Site
• Philippines
  • Makati, Philippines, 1229
    • Novartis Investigative Site
  • Pasig, Philippines, 1605
    • Novartis Investigative Site
  • NCR
    • Makati, NCR, Philippines, 1229
      • Novartis Investigative Site
• Puerto Rico
  • Arecibo, Puerto Rico, 00612
    • Emanuelli Research and Development Center LLC
• Russia
  • Cheboksary, Russia, 428028
    • Novartis Investigative Site
  • Moscow, Russia, 127473
    • Novartis Investigative Site
  • Moscow, Russia, 119021
    • Novartis Investigative Site
  • Moscow, Russia, 127486
    • Novartis Investigative Site
  • Omsk, Russia, 644024
    • Novartis Investigative Site
  • Sterlitamak, Russia, 453128
    • Novartis Investigative Site
  • Ulyanovsk, Russia, 432063
    • Novartis Investigative Site
  • Yekaterinburg, Russia, 620109
    • Novartis Investigative Site
• South Korea
  • Daegu, South Korea, 705703
    • Novartis Investigative Site
  • Seoul, South Korea, 06351
    • Novartis Investigative Site
  • Gyeonggi-do
    • Bundang Gu, Gyeonggi-do, South Korea, 13620
      • Novartis Investigative Site
  • Seocho Gu
    • Seoul, Seocho Gu, South Korea, 06591
      • Novartis Investigative Site
• Taiwan
  • Hualien City, Taiwan, 970
    • Novartis Investigative Site
  • Kaohsiung City, Taiwan, 80756
    • Novartis Investigative Site
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06100
    • Novartis Investigative Site
  • Ankara, Turkey (Türkiye), 06230
    • Novartis Investigative Site
  • Istanbul, Turkey (Türkiye), 34420
    • Novartis Investigative Site
  • Izmir, Turkey (Türkiye), 35340
    • Novartis Investigative Site
• United States
  • Arizona
    • Tucson, Arizona, United States, 85704
      • Retina Associates SW
  • California
    • Beverly Hills, California, United States, 90211
      • Retina- Vitreous Assoc Medical Group
    • Fullerton, California, United States, 92835
      • Retina Consultants of Orange County
    • Huntington Beach, California, United States, 92647
      • Salehi Retina Institute
    • Redlands, California, United States, 92374
      • Retina Consultants of Southern California
    • Torrance, California, United States, 90509-2910
      • Lundquist Inst BioMed at Harbor
    • Torrance, California, United States, 90505
      • Premiere Practice Management LLC
    • Ventura, California, United States, 93003
      • Miramar Eye Specialists
  • Florida
    • Deerfield Beach, Florida, United States, 33064
      • Rand Eye Institute
    • Deerfield Beach, Florida, United States, 33064
      • Advanced Research LLC
    • Fort Lauderdale, Florida, United States, 33309
      • Pinnacle Research Institute
    • Fort Myers, Florida, United States, 33912-7125
      • National Ophthalmic Research Institute
    • Jacksonville, Florida, United States, 32216
      • Florida Retina Institute
    • Lakeland, Florida, United States, 33801
      • Blue Oc Clin Res at Palm Bch Eye Ct
    • Miami, Florida, United States, 33143
      • Medeye Associates
    • Orlando, Florida, United States, 32804
      • Florida Retina Institute
    • Panama City, Florida, United States, 32405
      • Eye Center of North Florida
    • Plantation, Florida, United States, 33324
      • Fort Lauderdale Eye Institute
  • Illinois
    • Elmhurst, Illinois, United States, 60126
      • Retina Associates
  • Indiana
    • Indianapolis, Indiana, United States, 46280
      • Midwest Eye Institute
    • New Albany, Indiana, United States, 47150
      • John-Kenyon American Eye Institute PC
  • Kansas
    • Lenexa, Kansas, United States, 66215
      • Retina Associates PA
  • Maryland
    • Hagerstown, Maryland, United States, 21740
      • Cumberland Valley Retina Consultants
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi Med Ctr
  • Ohio
    • Cleveland, Ohio, United States, 44122
      • Retina Associates of Cleveland
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Dean McGee Eye Institute
  • Oregon
    • Springfield, Oregon, United States, 97477
      • Cascade Medical Research Institute
  • Pennsylvania
    • Erie, Pennsylvania, United States, 16507
      • Erie Retinal Surgery
  • South Carolina
    • Ladson, South Carolina, United States, 29456
      • Charleston Neuroscience Institute
  • Tennessee
    • Knoxville, Tennessee, United States, 37923
      • Southeastern Retina Associates P C
  • Texas
    • Austin, Texas, United States, 78705
      • Austin Retina Associates
    • Austin, Texas, United States, 78731
      • Texan Eye P A
    • Bellaire, Texas, United States, 77401
      • Retina Consultants TX Rsrch Ctr
    • Bellaire, Texas, United States, 77401
      • Retina and Vitreous of Texas
    • Fort Worth, Texas, United States, 76104
      • Texas Retina Associates
    • Harlingen, Texas, United States, 78550
      • Valley Retina Institute PA
    • Houston, Texas, United States, 77030
      • Retina Consultants of Houston PA
    • San Antonio, Texas, United States, 78240
      • Retina Associates of South Texas PA
    • San Antonio, Texas, United States, 78240
      • Medical Center Opthamology Assoc
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Virginia Eye Consultants

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Signed informed consent must be obtained prior to participation
• Able to complete adequate fundus photographs and retinal images
• Diagnosis of type 1 or 2 Diabetes Mellitus (DM) and HbA1c less than or equal to 12% at screening
• DM treatment stable for at least 3 months
• PDR diagnosis with no previous PRP treatment in the study eye

Exclusion Criteria:

• Concomitant conditions or ocular disorders in the study eye at Screening or Baseline that could compromise a response to study treatment.
• Presence of diabetic macular edema in the study eye
• Active infection or inflammation in the study eye
• Uncontrolled glaucoma (IOP greater than 25 mmHg)
• Intravitreal anti-VEGF treatment within 6 months
• Treatment with intraocular corticosteroids
• End stage renal disease requiring dialysis or kidney transplant
• Uncontrolled blood pressure
• Systemic anti-VEGF therapy at any time

Other protocol-defined inclusion/exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Brolucizumab 6 mg; Intra-vitreal injection. 3 x q6w loading injections, followed by q12w maintenance through Week 90	Biological: Brolucizumab 6 mg; 3 x q6w loading injections, followed by q12w maintenance through Week 90; Other Names: RTH258
Active Comparator: Panretinal photocoagulation laser Arm; Initial treatment in 1-4 sessions up to Week 12, followed with additional PRP treatment as needed	Procedure: Panretinal photocoagulation laser; initial treatment in 1-4 sessions up to Week 12, followed with additional PRP treatment as needed; Other Names: PRP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 54 for the Study Eye	BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of >= 34 ETDRS letters (Snellen equivalent 20/200) at Screening / Baseline in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better functioning. Last observation carried forward (LOCF) was used for the imputation of missing values.	Baseline, Week 54

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number and Percentage of Subjects With no Proliferative Diabetic Retinopathy (PDR) at Week 54 for the Study Eye	Proliferative diabetic retinopathy (PDR) is derived from the diabetic retinopathy severity scale (DRSS) as assessed by the central reading center (CRC) using 7-field color fundus photography image. The DRSS on the original score with scores varying from 10 (DR absent) to 85 (very advanced PDR) were then converted into a 12-level scale (Range is from 1 - diabetic retinopathy (DR) absent, to 12- very advanced PDR). (A lower score represents a better outcome.) The event of "No PDR" is then defined as DRSS (12-level scale) < 7.	Week 54
Number and Percentage of Subjects With no Proliferative Diabetic Retinopathy (PDR) at Week 96 for the Study Eye	Proliferative diabetic retinopathy (PDR) is derived from the diabetic retinopathy severity scale (DRSS) as assessed by the central reading center (CRC) using 7-field color fundus photography image. The DRSS on the original score with scores varying from 10 (DR absent) to 85 (very advanced PDR) were then converted into a 12-level scale (Range is from 1 - diabetic retinopathy (DR) absent, to 12- very advanced PDR). (A lower score represents a better outcome.) The event of "No PDR" is then defined as DRSS (12-level scale) < 7.	Week 96
Number and Percentage of Subjects With Center-involved Diabetic Macular Edema (CI- DME) up to Week 54 for the Study Eye	Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center. PRP = Panretinal photocoagulation laser	Up to Week 54
Number and Percentage of Subjects With Center-involved Diabetic Macular Edema (CI- DME) up to Week 96 for the Study Eye	Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center. PRP = Panretinal photocoagulation laser	Up to Week 96
Area Under the Curve in Change From Baseline in BCVA up to Week 54 and up to Week 96 - for the Study Eye	BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of >= 34 ETDRS letters (Snellen equivalent 20/200) at Screening / Baseline in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better functioning. Last observation carried forward (LOCF) was used for the imputation of missing values. The AUC in change from Baseline in BCVA up to Week 54 (or Week 96) is referred to as the averaged change from Baseline in BCVA at each visit up to 54 (or Week 96), which was calculated as (BCVA at Week 6 + BCVA at Week 12 + ... + BCVA at Week 54 (or Week 96)) / number of visits with valid BCVA data from Week 6 to Week 54 (or Week 96) - BCVA at Baseline.	Baseline, up to Week 54 and up to Week 96
Diabetic Retinopathy Severity Scale (DRSS): Number and Percentage of Subjects With ≥2 Steps Improvement From Baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) DRSS Score at Week 54 and Week 96	Severity of Diabetic retinopathy was evaluated using the ETDRS DRSS score assessed by the Central Reading Center based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on the original scale with scores varying from 10 (DR absent) to 85 (very advanced PDR). All DRSS values were then converted into a 12-level scale, allowing the derivation of the ≥2-step and ≥3-step change from baseline for each post-baseline assessment". A lower score represents better functioning.	Baseline, Week 54 and Week 96
Diabetic Retinopathy Severity Scale (DRSS): Number and Percentage of Subjects With ≥2 Steps Worsening From Baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) DRSS Score at Week 54 and Week 96	Severity of Diabetic retinopathy was evaluated using the ETDRS DRSS score assessed by the Central Reading Center based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on the original scale with scores varying from 10 (DR absent) to 85 (very advanced PDR). All DRSS values were then converted into a 12-level scale, allowing the derivation of the ≥2-step and ≥3-step change from baseline for each post-baseline assessment". A lower score represents better functioning.	Baseline, Week 54 and Week 96
Diabetic Retinopathy Severity Scale (DRSS): Number and Percentage of Subjects With ≥3 Steps Improvement From Baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) DRSS Score at Week 54 and Week 96	Severity of Diabetic retinopathy was evaluated using the ETDRS DRSS score assessed by the Central Reading Center based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on the original scale with scores varying from 10 (DR absent) to 85 (very advanced PDR). All DRSS values were then converted into a 12-level scale, allowing the derivation of the ≥2-step and ≥3-step change from baseline for each post-baseline assessment". A lower score represents better functioning.	Baseline, Week 54 and Week 96
Diabetic Retinopathy Severity Scale (DRSS): Number and Percentage of Subjects With ≥3 Steps Worsening From Baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) DRSS Score at Week 54 and Week 96	Severity of Diabetic retinopathy was evaluated using the ETDRS DRSS score assessed by the Central Reading Center based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on the original scale with scores varying from 10 (DR absent) to 85 (very advanced PDR). All DRSS values were then converted into a 12-level scale, allowing the derivation of the ≥2-step and ≥3-step change from baseline for each post-baseline assessment". A lower score represents better functioning.	Baseline, Week 54 and Week 96
Number and Percentage of Subjects Developing Vision-threatening Complications Associated With Diabetic Retinopathy up to Week 54 and up to Week 96	The vision-threatening complications associated with Diabetic retinopathy (DR) are defined as any event of the following list occurring in the study eye at any time point after Baseline: Center-involved Diabetic macular edema (CI-DME) as defined as Central sub-field thickness (CSFT) ≥280 µm according to Central reading center (CRC) evaluation of Optical coherent tomography (OCT) image; Retinal detachment; Vitreous hemorrhage; Neovascular glaucoma, iris/ anterior chamber angle neovascularization; Vitrectomy for DR complications	up to Week 54 and up to Week 96
Ocular AEs (>= 2% in Any Treatment Arm) by Preferred Term for the Study Eye	An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a subject or clinical investigation subject. AEs that started after alternative diabetic retinopathy treatment/relevant diabetic macular edema treatment in the study eye are censored.	Adverse events are reported from first dose of study treatment up to Week 90, plus approximately 6 weeks post-treatment, up to a maximum timeframe of approximately 96 weeks.
Non-ocular AEs (≥ 2% in Any Treatment Arm) by Preferred Term	An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a subject or clinical investigation subject. AEs that started after alternative diabetic retinopathy treatment/relevant diabetic macular edema treatment in the study eye are censored.	Adverse events are reported from first dose of study treatment up to Week 90, plus approximately 6 weeks post-treatment, up to a maximum timeframe of approximately 96 weeks.

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Publications and helpful links

Helpful Links

• A Plain Language Trial Summary is available on www.novctrd.com

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2020
• Primary Completion (Actual): October 30, 2023
• Study Completion (Actual): August 19, 2024

Study Registration Dates

• First Submitted: February 18, 2020
• First Submitted That Met QC Criteria: February 18, 2020
• First Posted (Actual): February 20, 2020

Study Record Updates

• Last Update Posted (Estimated): October 16, 2025
• Last Update Submitted That Met QC Criteria: October 8, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: proliferative diabetic retinophathy, retinal neovascularization, anti-VEGF, brolucizumab, intravitreal injection, panretinal photocoagulation
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Retinal Diseases; Metaplasia; Neovascularization, Pathologic; Pathological Conditions, Signs and Symptoms; Retinal Neovascularization; brolucizumab
• Other Study ID Numbers: CRTH258D2301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No